OVY by Beurer - Bluetooth Basal Thermometer with Ovy App - BEURER NORTH AMERICA, L.P.

Duns Number:078497467

Device Description: Bluetooth Basal Thermometer with Ovy App

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

791.77

Brand Name

OVY by Beurer

Version/Model Number

OT30

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

LHD

Product Code Name

Device, Fertility Diagnostic, Proceptive

Device Record Status

Public Device Record Key

24b4332a-50fb-4ed7-836b-c4c74722c2a8

Public Version Date

June 09, 2020

Public Version Number

1

DI Record Publish Date

June 01, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BEURER NORTH AMERICA, L.P." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 90
U Unclassified 2